DeviceClearance

K023162

Substantially Equivalent

FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS

Applicant
Fresenius Medical Care
Product code
FIE
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Lexington, MA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code FIE

product code FIE
Death
2
Total
2

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.